Bruce E Sands, David T Rubin, Edward V Loftus, Douglas C Wolf, Remo Panaccione, Jean-Frederic Colombel, Axel Dignass, Miguel Regueiro, Severine Vermeire, Anita Afzali, Garrett Lawlor, Harris A Ahmad, Hsiuanlin Wu, Mark T Osterman, Anjali Jain, Geert D'Haens
{"title":"Impact of Prior Biologic Exposure on Ozanimod Efficacy and Safety in the Phase 3 True North Clinical Trial.","authors":"Bruce E Sands, David T Rubin, Edward V Loftus, Douglas C Wolf, Remo Panaccione, Jean-Frederic Colombel, Axel Dignass, Miguel Regueiro, Severine Vermeire, Anita Afzali, Garrett Lawlor, Harris A Ahmad, Hsiuanlin Wu, Mark T Osterman, Anjali Jain, Geert D'Haens","doi":"10.14309/ajg.0000000000003310","DOIUrl":"https://doi.org/10.14309/ajg.0000000000003310","url":null,"abstract":"<p><strong>Introduction: </strong>Patients with ulcerative colitis (UC) and prior biologic failure may have reduced or delayed efficacy with subsequent advanced therapies. This analysis evaluated the efficacy and safety of ozanimod during the True North (TN) study and its open-label extension (OLE) in biologic-exposed patients with UC.</p><p><strong>Methods: </strong>TN was a randomized, placebo-controlled 52-week trial (10-week induction, 42-week maintenance period). Eligible patients could enter the OLE. Clinical outcomes were assessed at TN Week (W) 10 and W52 and OLE W46 and W94. Symptomatic efficacy was evaluated through induction and in the OLE until W94. Safety was assessed.</p><p><strong>Results: </strong>This analysis included 376 biologic-exposed patients. In the placebo-controlled cohort, more ozanimod-treated patients achieved clinical response than placebo at W10 regardless of the number or type of prior biologics; patients who used 1 versus ≥2 prior biologics achieved higher efficacy rates. Efficacy rates were higher at W52 than W10 and were similar across subgroups regardless of the number or type of prior biologics. Significantly greater proportions of ozanimod vs placebo patients achieved symptomatic response by W5 (P=0.0173) and symptomatic remission by W10 (P=0.0207). Among biologic-exposed TN W10 ozanimod nonresponders who entered the OLE, 61% achieved symptomatic response with an extra 10 weeks of ozanimod treatment. Ozanimod efficacy was durable for ∼3 years of continuous treatment in biologic-exposed W52 clinical responders who entered the OLE. No new safety signals were observed.</p><p><strong>Conclusions: </strong>Ozanimod was effective and safe in biologic-exposed patients with UC, but these patients may require more time to respond to treatment.</p>","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142942719","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Nayna A Lodhia, Brent Hiramoto, Laura Horton, Alison H Goldin, Walter W Chan
{"title":"Obesity is Independently Associated with Increased Risk of Fecal Incontinence and Altered Rectal Sensitivity.","authors":"Nayna A Lodhia, Brent Hiramoto, Laura Horton, Alison H Goldin, Walter W Chan","doi":"10.14309/ajg.0000000000003308","DOIUrl":"https://doi.org/10.14309/ajg.0000000000003308","url":null,"abstract":"<p><strong>Background: </strong>Hindgut symptoms are poorly understood complications of obesity. The impact of obesity on fecal incontinence (FI) and anorectal physiology remains unclear, with inconsistent results in prior studies. We aimed to evaluate the relationship between obesity and FI, and the physiological changes in anorectal function.</p><p><strong>Methods: </strong>This was a retrospective cohort study of consecutive adults who underwent high-resolution anorectal manometry (HRAM) at a tertiary center for anorectal symptoms. Demographics, clinical history, surgical/obstetric history, medications and HRAM findings were reviewed. Patients were classified as non-obese (BMI <25 kg/m2), overweight (BMI 25-29.9 kg/m2), class I obesity (30-34.9 kg/m2), and class II+III obesity (>35 kg/m2). Fisher-exact/student t-test for univariate analyses and logistic/general linear regression for multivariable analyses were performed.</p><p><strong>Results: </strong>552 adults were included. Mean BMI was higher among patients with FI (27.5 vs 25.9 kg/m2, p=0.013). Compared to non-obese group, FI was more prevalent in class II+III obesity (31.7% vs 13.2%, p=0.0024), but not class I obesity or overweight groups. On multivariable analysis controlling for potential confounders, class II+III obesity (adjusted OR 2.89, CI:1.28-6.50, p=0.02) remained an independent risk factor for FI. Among patients with FI, both BMI (β-coefficient 1.09, p=0.016) and class II+III obesity (β-coefficient 18.9, p=0.027) independently predicted increased first rectal sensation volume on HRAM on multivariable regression.</p><p><strong>Conclusions: </strong>Classes II+III obesity was an independent risk factor for FI. Among patients with FI, increasing BMI and class II+III obesity were associated with altered rectal sensitivity. Anorectal function testing should be considered to help guide management of FI among patients with obesity.</p>","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142942721","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Comment on \"Fecal Immunochemical to Detect Colorectal Neoplasia in Lynch Syndrome: A Prospective Multicenter Study\".","authors":"Xiaoxia Liu, Zhang Chong-Jie","doi":"10.14309/ajg.0000000000003247","DOIUrl":"https://doi.org/10.14309/ajg.0000000000003247","url":null,"abstract":"","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142942716","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Zoe Memel, Amy Yu, Cynthia Fenton, Timothy Wen, Roxanna A Irani, Li Zhang, Uma Mahadevan
{"title":"The Effect of Low-dose Aspirin on Disease Activity in Pregnant Individuals with Inflammatory Bowel Disease.","authors":"Zoe Memel, Amy Yu, Cynthia Fenton, Timothy Wen, Roxanna A Irani, Li Zhang, Uma Mahadevan","doi":"10.14309/ajg.0000000000003304","DOIUrl":"https://doi.org/10.14309/ajg.0000000000003304","url":null,"abstract":"<p><strong>Objectives: </strong>Low-dose aspirin (LDA) is recommended for pregnant individuals at elevated risk for hypertensive disorders of pregnancy (HDP). However, regular aspirin use may raise concerns of increased disease activity in patients with inflammatory bowel disease (IBD). We aimed to evaluate the prevalence of LDA use in pregnant IBD patients and the effect of LDA on IBD disease activity.</p><p><strong>Methods: </strong>Included were individuals with IBD and pregnancy followed by Maternal Fetal Medicine (MFM) between 1/1/2013-12/31/2022. LDA use was ascertained from medication lists during pregnancy. Primary outcome was IBD flare during pregnancy or six months postpartum, defined as IBD-related hospitalization or surgery, new therapy initiation, elevated fecal calprotectin, or new active endoscopic disease.</p><p><strong>Results: </strong>Among 320 pregnancies in women with IBD (232 patients), 90 (28%) were prescribed aspirin during pregnancy. The percentage of women with IBD flare during pregnancy or postpartum was similar among those who were and were not prescribed aspirin (20% vs 26%, p=0.36). Individuals on aspirin were older (35 vs 34 median years), more likely to have preterm birth (21% vs 14%), higher parity (2 vs 1), and cesarean delivery (50% vs 27%) than individuals not on LDA, (all p<0.01). Both groups had similar rates of HDP, though individuals on LDA had higher rates of preeclampsia (10% vs 4.3%, p=0.10).</p><p><strong>Conclusion: </strong>Approximately one-third of patients with IBD cared for in a MFM practice were prescribed LDA during pregnancy. The use of aspirin among pregnant patients with IBD was not associated with an increased risk of disease activity.</p>","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142942724","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Triad of Challenge: Hydatid Cyst in Liver, Lung, and Spleen.","authors":"Sweta Rose, Sagun Baral, Sunil Taneja","doi":"10.14309/ajg.0000000000003303","DOIUrl":"10.14309/ajg.0000000000003303","url":null,"abstract":"","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142942725","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sebastian Niezen, Timothy R Morgan, Dawn Scott, Vera Yakovchenko, Heather Patton, Patrick Spoutz, Yiwen Yao, Gyorgy Baffy, Michael Fuchs, Jasmohan S Bajaj, Nsikak R Ekanem, Jason A Dominitz, Shari S Rogal
{"title":"Identifying and treating metabolic dysfunction-associated steatotic liver disease among at-risk Veterans.","authors":"Sebastian Niezen, Timothy R Morgan, Dawn Scott, Vera Yakovchenko, Heather Patton, Patrick Spoutz, Yiwen Yao, Gyorgy Baffy, Michael Fuchs, Jasmohan S Bajaj, Nsikak R Ekanem, Jason A Dominitz, Shari S Rogal","doi":"10.14309/ajg.0000000000003312","DOIUrl":"https://doi.org/10.14309/ajg.0000000000003312","url":null,"abstract":"<p><strong>Objectives: </strong>Metabolic dysfunction-associated steatotic liver disease (MASLD), an increasing public health concern, remains challenging to diagnose and risk-stratify. We assessed the 1) prevalence of MASLD risk factors among Veterans in Veterans Health Administration (VA) care, 2) factors associated with MASLD diagnosis; and 3) associations between MASLD diagnosis and receipt of care.</p><p><strong>Methods: </strong>Veterans with MASLD risk factors, including obesity, pre-diabetes, diabetes, or dyslipidemia, were identified using International Classification of Diseases-10 codes and followed in 2019-2022. Multivariable logistic regression and propensity score-adjusted models identified demographic and clinical characteristics associated with a diagnosis of MASLD or cirrhosis and receipt of elastography, specialty care for liver disease, VA weight management (MOVE!) participation, and glucagon-like peptide-1 (GLP-1) analog prescriptions.</p><p><strong>Results: </strong>Among approximately 9 million Veterans, 4,159,699 (45%) had risk factors for MASLD and were included in further analysis. MASLD or cirrhosis was diagnosed in 6% of the at-risk cohort. At-risk Veterans diagnosed with MASLD were younger with more metabolic risk factors, increased rates of alcohol use disorder, and higher FIB-4 scores and ALT values. Over one-year follow-up, 6% engaged in MOVE!, 9% had specialty care for liver disease, 3% were prescribed GLP-1 analogs, and 2% underwent staging elastography. MASLD diagnosis was significantly associated with receipt of MOVE!, specialty care consultation, and GLP-1 analog prescription.</p><p><strong>Conclusions: </strong>Few at-risk Veterans carried a MASLD diagnosis or had undergone staging elastography. Because MASLD diagnosis was associated with linkage to hepatology care and weight loss therapy services, implementation of population screening and management services for MASLD is critically needed.</p>","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142942718","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ekaterina Plys, Jean-Luc Bulliard, Aziz Chaouch, Marie-Anne Durand, Luuk A van Duuren, Karen Braendle, Reto Auer, Florian Froehlich, Iris Lansdorp Vogelaar, Douglas A Corley, Kevin Selby
{"title":"Colorectal cancer screening based on predicted risk: a randomized controlled trial.","authors":"Ekaterina Plys, Jean-Luc Bulliard, Aziz Chaouch, Marie-Anne Durand, Luuk A van Duuren, Karen Braendle, Reto Auer, Florian Froehlich, Iris Lansdorp Vogelaar, Douglas A Corley, Kevin Selby","doi":"10.14309/ajg.0000000000003311","DOIUrl":"https://doi.org/10.14309/ajg.0000000000003311","url":null,"abstract":"<p><strong>Introduction: </strong>Colorectal cancer (CRC) screening relies primarily on colonoscopy and fecal immunochemical testing (FIT). Aligning utilization of these options with individual CRC risk may optimize benefit with lower risks, individual burden, and societal costs. We studied the effect of communicating personalized CRC risk and corresponding screening recommendations on risk-appropriate screening uptake in an organized screening setting.</p><p><strong>Methods: </strong>Randomized controlled trial among residents aged 50-69 years not yet invited for screening in Vaud, Switzerland. The intervention was a mailed brochure communicating individual 15-year CRC risk and screening recommendation. The control group received a usual brochure comparing FIT and colonoscopy. The primary outcome was self-reported risk-appropriate screening (FIT if <3% risk, FIT or colonoscopy if ≥3% and <6%, colonoscopy if ≥6%) at 6 months. A secondary outcome was overall screening uptake.</p><p><strong>Results: </strong>Of 5396 invitations, 1059 people responded (19%), of whom 258 were randomized to intervention and 257 to control materials (average 15-year risk 1.4% (SD=0.5), age 52.2 years (SD=2.2), 51% women). Risk-appropriate screening completion was 37% in the intervention group and 23% in the control group (absolute difference 14%, 95%CI 6%-22%). Overall screening uptake was 50% in the intervention and 49% in the control group (absolute difference 1%, 95CI -7%-10%).</p><p><strong>Conclusions: </strong>In a population not known to be at elevated CRC risk, brochures providing personalized CRC risk and screening recommendations improved risk-appropriate screening without impacting overall screening uptake. This approach could be helpful for aligning screening methods, risks, and benefits with cancer risk and resource allocation.</p>","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142942715","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Mesenteric Arteriovenous Fistula: A Rare Cause of Gastrointestinal Bleeding in Children.","authors":"Ran Tang, Rui Dong","doi":"10.14309/ajg.0000000000003294","DOIUrl":"10.14309/ajg.0000000000003294","url":null,"abstract":"","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142930510","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Removal of a Chronically Embedded Coin From the Esophageal Wall Using the \"Stent-in-Stent\" Approach in a Child.","authors":"Andrew Canakis, Sabina Mir, Todd H Baron","doi":"10.14309/ajg.0000000000003289","DOIUrl":"10.14309/ajg.0000000000003289","url":null,"abstract":"","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142930589","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Michael J Langevin, Christopher D Jensen, Amy R Marks, Sophie A Merchant, Jessica Badalov, Jeffrey K Lee, Angela Y Lam, Ethan A Halm, Theodore R Levin
{"title":"Rebound in Fecal Testing, Colonoscopy Utilization, and Colorectal Neoplasia Detection During the COVID-19 Pandemic.","authors":"Michael J Langevin, Christopher D Jensen, Amy R Marks, Sophie A Merchant, Jessica Badalov, Jeffrey K Lee, Angela Y Lam, Ethan A Halm, Theodore R Levin","doi":"10.14309/ajg.0000000000003293","DOIUrl":"10.14309/ajg.0000000000003293","url":null,"abstract":"<p><strong>Introduction: </strong>The COVID-19 pandemic reduced colorectal cancer (CRC) screening, but the rebound in testing and outcomes after the pandemic has not been widely reported. We evaluated CRC test utilization and colorectal neoplasia detection among screening eligible patients in a large health system in 2020 and 2021, compared with 2019 (prepandemic).</p><p><strong>Methods: </strong>Using a retrospective cohort study design, fecal immunochemical test (FIT) and colonoscopy utilization, FIT positivity, and neoplasia detection were evaluated annually in 2019-2021 among Kaiser Permanente Northern California patients aged 50-75 years overall and by sex, age, race and ethnicity, and spoken language preference.</p><p><strong>Results: </strong>Compared with 2019, reductions in FIT, colonoscopy, FIT positivity, and neoplasia detection in 2020 were followed by a strong rebound in 2021 and no subgroups by age and sex or minority subgroups by race and ethnicity or spoken language preference demonstrably lagged in their recovery in 2021. Among White persons and those with an English language preference, there was a small lag in recovery to baseline levels. The overall decline in CRC testing by colonoscopy in 2020 was offset by a lesser decrease in FIT utilization in 2020, and a strong rebound in FIT utilization in 2021 helped to offset the small lag in the rebound in colonoscopies completed in 2021.</p><p><strong>Discussion: </strong>Findings may help guide organizations looking to improve CRC screening and minimize health care disparities related to national emergencies such as pandemics. Long-term studies are needed to evaluate how pandemic-related changes in CRC screening practices will affect future CRC outcomes.</p>","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142930517","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}